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Acute Myeloid LeukemiaPhase 2DEXAML-02NCT03609060

Dexamethasone Added to Intensive Chemotherapy in Older Patients with Acute Myeloid Leukemia (AML)

A Phase 2 study testing Dexamethasone in people with Acute Myeloid Leukemia, run by French Innovative Leukemia Organisation at 25 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Recent preclinical and clinical data strongly suggested that dexamethasone could improve the activity of intensive chemotherapy in AML. In this study, the FILO study group will assess the impact of adding dexamethasone to both induction and consolidation therapy in older AML patients with intermediate or favorable… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
25 sitesFrance
Study dates
24 Aug 2018to 31 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • > 60 years of age.
  • Newly diagnosed AML according to the World Health Organization (WHO) 2016 either de novo AML or therapy-related AML (i.e AML arising after previous cytotoxic therapy or radiation)
  • AML with favorable or intermediate cytogenetic risk according to Medical Research Council (MRC 2010) classification.
  • Subjects should be eligible for intensive chemotherapy by Idarubicin, cytarabine, Lomustine.
  • Eastern Cooperative Oncology Group (ECOG) performance status < 3 (appendix 1).
  • SORROR score ≤ 3 (appendix 2).
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  • Adequate baseline organ function defined by the criteria below:
  • Total bilirubin ≤ 1.5 x Upper Limit of Normal (ULN) unless bilirubin rise is due to Gilbert's syndrome
  • Alanine Aminotransferase (ALAT) and Aspartate Transaminase (ASAT) ≤ 3xULN
  • creatinin clearance (Cockcroft-Gault) ≥ 30 ml/min
  • Unless considered due to leukemic organ involvement
  • Adequate cardiac function with Left Ventricular Ejection Fraction (LVEF) ≥50%
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
  • Women will be menopausal to be enrolled
  • The patient must give written (personally signed and dated) informed consent before completing any study-related procedure which means assessment or evaluation that would not form part of the normal medical care of the patient and before the start of induction chemotherapy.
  • Affiliated to the French Social Security (Health Insurance).

Who cannot join

  • Acute promyelocytic leukemia (APL) or acute megakaryocytic leukemia (AML-FAB M7).
  • AML with adverse cytogenetic risk according to the MRC 2010 classification.
  • AML arising from myelodysplastic syndromes, myeloproliferative disorders or chronic myelo-monocytic leukemia according to WHO classification (2016).
  • AML with Philadelphia chromosome or with BCR-ABL1.
  • Known active central nervous system leukemia
  • Previous anti-AML treatment other than hydroxyurea.
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  • Cumulative anthracycline dose equivalent to ≥550 mg/m².
  • Treatment with an investigational drug within 30 days or 5 half-life whichever is longer, preceding the first dose of study medication.
  • Prior history of cancer unless controlled for at least 2 years and except for basal cell carcinoma, non-melanoma skin cancer and in situ cervical carcinoma.
  • Severe medical or mental condition precluding the administration of protocol treatments
  • Any sign of active uncontrolled disease including but not restricted to cardiac disease, infections, hepatitis.
  • Any severe chronic disease potentially interfering with the protocol including HIV infection, active hepatitis B or C.
  • Any severe conditions inducing contra-indications to dexamethasone including uncontrolled diabetes, infections, hypertension, stomach ulcer, mental illness, myasthenia or glaucoma.
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would place the participant at an unacceptable risk or prevent them from giving informed consent.
  • Known active HIV, Hepatitis B or C infection.
  • Pregnancy or breastfeeding.
  • Patients who are incapacitated, under wardship, legal guardianship, or under the protection of the courts.
  • Patients under State Medical Assistance (AME).

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

France25 sites

  • CHU ANGERS - Maladies du sang

    Angers, 49933

  • Ch Avignon

    Avignon, 84000

  • CH de la Côte Basque - Hématologie

    Bayonne, 64109

  • CHRU JEAN MINJOZ - Hématologie

    Besançon, 25030

  • CH de Béziers - Hématologie

    Béziers, 34500

  • CHU Brest - Hôpital Morvan - Hématologie Clinique

    Brest, 29609

  • Clinique du Parc - Hématologie

    Castelnau-le-Lez, 34170

  • CHU Estaing - Hématologie Clinique Adulte

    Clermont-Ferrand, 63000

  • CHU Grenoble - Hématologie Clinique

    Grenoble, 38043

  • Institut Paoli-Calmettes - Hématologie 2

    Marseille, 13000

  • CHR de Mercy - Hématologie

    Metz, 57085

  • Hôpital Saint-Eloi - Hématologie Clinique

    Montpellier, 34295

  • HOPITAL E. MULLER - Hématologie

    Mulhouse, 68070

  • CHU HOTEL DIEU - Hématologie Clinique

    Nantes, 44093

  • CHR ORLEANS - Hématologie

    Orléans, 44100

  • HOPITAL COCHIN - Hématologie

    Paris, 75014

  • CENTRE HOSPITALIER SAINTJEAN - Hématologie Clinique

    Perpignan, 66000

  • Hôpital Haut Levêque- CFM -Hématologie Clinique Et Thérapie Cellulaire

    Pessac, 33604

  • CHU La Milétrie - Hématologie Clinique

    Poitiers, 86000

  • CHU Reims - Hôpital Robert Debré - Hématologie Clinique

    Reims, 51100

  • CHU Pontchaillou - Hématologie

    Rennes, 35033

  • CHU Hautepierre - Hématologie

    Strasbourg, 67098

  • Institut Universitaire du Cancer de Toulouse Oncopole - Service d'Hématologie

    Toulouse, 31059

  • CHU Bretonneau - Centre Henri Kaplan - Hématologie et Thérapie Cellulaire

    Tours, 37044

  • CHU Nancy - Hopitaux Brabois

    Vandœuvre-lès-Nancy, 54500

Other trials in France

About this study

Official title: A Phase II Study of Dexamethasone Added to Induction and Post-remission Therapy in Older Patients with Newly Diagnosed Acute Myeloid Leukemia (AML)

Recent preclinical and clinical data strongly suggested that dexamethasone could improve the activity of intensive chemotherapy in AML. In this study, the FILO study group will assess the impact of adding dexamethasone to both induction and consolidation therapy in older AML patients with intermediate or favorable risk.

Read the detailed description

Patients will receive dexamethasone in addition to induction and post-remission chemotherapy

The principal objective of the study is to determine whether adding dexamethasone to induction and post-remission therapy results in significant improvement of event-free survival (EFS) as compared with an historical cohort of the FILO LAM-SA 2007 trial.

Induction therapy: Idarabucin + Cyrarabine + Lomustine (ICL) + Dexamethasone. Idarubicin 8 mg/m²/day, IV over 15 minutes, D1 to D5; Cytarabine 100 mg/m²/d, IV continuous 24h-infusion D1 to D7; Lomustine 200 mg/m²/d, orally at D1; Dexamethasone 10 mg/12h, IV over 30 minutes, D1 to D3.

Post remission therapy: Idarabucin + Cyrarabine (IC) + Dexamethasone

Idarubicin 8 mg/m², IV over 15 minutes, D1; Cytarabine 50 mg/m²/12h, subcutaneous, D1 to D5; Dexamethasone 20 mg/d, IV over 30 minutes, D1.

Being tested
Dexamethasone
Keywords
Elderly patients
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexamethasoneDrug

    Dexamethasone 10 mg/12h, IV over 30 minutes, D1 to D3 concomitant to induction and post remission chemotherapy in elderly patients with AML Induction

Study groups in NCT03609060
Study groupRoleWhat they receive
DEXAMLExperimentalInduction therapy: Idarubicin 8 mg/m²/day, IV over 15 minutes, D1 to D5 + Cytarabine 100 mg/m²/d, IV continuous 24h-infusion D1 to D7 + Lomustine 200 mg/m²/d, orally at D1 + Dexamethasone 10 mg/12h, IV over 30 minutes, D1 to D3. Addition of midostaurin in patients with Fms-like tyrosine kinase 3-internal tandem ( FLT3-ITD) or Fms-like tyrosine kinase 3-tyrosine kinase domain (FLT3-TKD) mutations is allowed. Post remission therapy: Idarubicin 8 mg/m², IV over 15 minutes, D1 + Cytarabine 50 mg/m²/12h, subcutaneous, D1 to D5 + Dexamethasone 20 mg/d, IV over 30 minutes, D1. Addition of midostaurin in patients with FLT3-ITD or FLT3-TKD mutations is allowed. Intermediate dose cytarabine is allowed for patients with Core Binding Factor AML (CBF-AML). Allogeneic stem-cell transplantation allowed after 2 to 4 cycles
Receives: Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event Free survival (EFS)

    Time from the date of induction start to the date of induction failure, relapse from CR or CRi, or death from any cause, whichever occurs first. CR, CRi, relapse from CR or CRi and induction failure are defined according to the ELN 2017 recommendations

    Measured: Within 2 years after the start of the Treatement

Secondary outcomes (7)

  1. Treatment response

    Response to therapy after induction therapy defined as CR or CRi according to the 2017 European Leukemia Net (ELN) recommendations.

    Measured: Up to 45 day

  2. Minimal Residual Disease (MRD)

    Presence of MRD after induction therapy and after post-remission therapy, measured by either quantitative PCR or flow cytometry

    Measured: Up to day 45 after induction chemotherapy, second and last consolidation cycle.

  3. Allogenic Stem Cells Transplantation (ASCT)

    Number of patients with ASCT

    Measured: Up to one year

  4. Remission duration (relapse from CR or CRi)

    Time from the date of CR or CRi to the date of relapse according to the 2017 ELN recommendations

    Measured: two years

  5. Relapse Free Survival (RFS)

    Time from the date of CR or CRi to the date of relapse or death from any cause, whichever occurs first, according to the ELN 2017 recommendations

    Measured: two years

  6. Overall Survival (OS)

    Time from the date of randomization to the date of death from any cause

    Measured: two years

  7. Adverse events

    Incidence and severity of Adverse Events according to the descriptions and grading scale found in the National Cancer Institute - Common Terminology Criteria (NCI-CTC) criteria v4.03

    Measured: up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2018
  2. Study start24 Aug 2018
  3. Primary completion31 Aug 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03609060
Sponsor's protocol ID
DEXAML-02 (LAM-SA 2018)
Acronym
DEXAML-02
Status last verified
Oct 2024
First submitted
28 Jun 2018
Last updated
29 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexamethasone in people with Acute Myeloid Leukemia, run by French Innovative Leukemia Organisation at 25 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event Free survival (EFS) (time frame: Within 2 years after the start of the Treatement). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03609060.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.

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